What you will do
- Lets do this. Lets change the world. In this vital role you will Provide technical solutions to programming problems within CfOR
- Lead and develop technical programming and process improvement initiatives within CfOR
- Design data quality enhancements
- Represent the programming function and participate in multidisciplinary project team meetings
- Project manage all programming activities, according to agreed resource and timeline plans
- Ensure all programming activities on the project adhere to departmental standards
- Write and/or review and approve all programming plans
- Write and/or review and approve analysis dataset specifications
- Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, etc.
- Write, test and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications
- Write, test, validate and complete department-, product- and protocol-level macros and utilities
- Be responsible for the work of outsourced resources assigned to project
- Lead and/or participate in the development and review of CfOR Policies, SOPs and other controlled documents
- Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings
- Participate in the recruitment of programming staff
- Actively participate in external professional organizations, conferences and/or meetings
- Provide input to and participate in intra-departmental and CfOR meetings
- Contribute to the continuous improvement of programming, CfOR, and Research and Development (R&D)
- Manage staff performance and oversee staff assignments and utilization
What we expect of you
- We are all different, yet we all use our unique contributions to serve patients. This crucial role involves leading a team of senior statistical programmers who will generate Real-World Evidence (RWE) to support Amgen products throughout the drug development lifecycle. This lead programming role will collaborate with teams across multiple time zones to oversee request fulfillment, clarify requirements, track projects, resolve issues, and deliver high-quality results. The Biostatistical Programming Manager will report to a locally based Director of Biostatistical Programming.
- The Biostatistical Programming Manager will be responsible for both hands-on programming as well as guiding junior programmers. Additionally, they will be responsible for manipulating large databases and generating reports to enable epidemiologists to explore and generate RWE from real-world healthcare data assets. The ideal candidate should possess a bachelors degree and have at least six years of relevant career experience in statistical programming. Proficiency in SAS and SQL programming is required, while experience with R and Python is preferred. The successful candidate will demonstrate scientific and technical excellence, exceptional oral and written communication skills, problem-solving abilities, and meticulous attention to detail. The ability to work effectively within a large, globally distributed team is essential
Basic Qualifications:
- Bachelors degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject.
- At least 68 years of relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting
Preferred Qualifications:
- Masters degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
- Training or experience using the Observational Medical Outcomes Partnership (OMOP) common data model
Experience:
- Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials
- Team management
- Global collaboration
- Request fulfillment oversight, clarifying requirements, project tracking, project fulfillment, statistical programming, issue resolution, expert resource, results delivery
- Statistical programming: SAS and SQL required; R and Python preferred
- Experience working with real-world healthcare data (RWD) such as healthcare claims (MarketScan, Optum Clinformatics, Medicare) and EHR databases (Optum EHR PanTher, Flatiron, CPRD, MDV)
Key Competencies
- Hands-on programming and lead role
- Expert statistical programming knowledge using SAS or R
- Required: SAS
- Required: SQL
- Required: Experience with data quality or data quality platforms (for example: Informatica, Ataccama)
- Preferred: Python
- Preferred: R
- Excellent verbal and written communication skills in English
- Ability to have efficient exchanges with colleagues across geographical locations
- Agile project management
- Real-world data (RWD) including insurance claims databases, electronic medical records and patient registries; for example, MarketScan, Optum, PharMetrics, Flatiron, Medicare
- OMOP common data model
- Drug development life cycle
- Statistics and basic epidemiology: Incidence and prevalence
- Scientific / technical excellence
- Oral and written communication, documentation skills
- Leadership
- Innovation
- Teamwork
- Problem solving
- Attention to detail
